FDA Reinstates Top Vaccines Regulator Vinay Prasad

The FDA has reinstated Vinay Prasad as director of the Center for Biologics Evaluation and Research, just ten days after he abruptly departed the agency. Prasad's return comes at the FDA's request.

The Food and Drug Administration (FDA) has reinstated Dr. Vinay Prasad as the director of the Center for Biologics Evaluation and Research (CBER), just ten days after his abrupt departure. The move comes at the FDA's request, according to a statement from the Department of Health and Human Services (HHS) spokesperson Andrew Nixon [1].

Dr. Prasad's tenure as CBER director had been marked by controversy, including his decision to impose stricter approval guidelines for COVID-19 vaccines and his intervention in the approval process for gene therapy treatments. His resignation followed a dispute with Sarepta Therapeutics over the approval of its gene therapy treatment, Elevidys, for boys with Duchenne muscular dystrophy [2].

Prior to his resignation, Dr. Prasad had been in the role for less than three months. His appointment was seen as a replacement for Peter Marks, who had resigned after clashing with HHS Secretary Robert F. Kennedy Jr. [3].

Dr. Prasad's return to the FDA comes amidst ongoing political and regulatory tensions. His critics, including right-wing influencer Laura Loomer, have accused him of being a "saboteur" and a "trojan horse" for HHS's "Make America Healthy Again" initiative [1].

The reinstatement of Dr. Prasad has sparked further debate about the influence of political forces on FDA decision-making. Some analysts have suggested that the move may indicate a shift in the agency's approach to regulatory flexibility, which had been championed by Dr. Marks [2].

References:

[1] https://www.aol.com/fda-reinstates-ousted-top-vaccine-170557461.html
[2] https://www.biopharmadive.com/news/vinay-prasad-cber-return-fda-vaccines-gene-therapy/757263/
[3] https://www.statnews.com/2025/08/09/vinay-prasad-returns-to-the-fda-weeks-after-his-ouster/